Senior Manager, Quality Asset Management

Biopharma Careers; Brussel Hoofdstad; Sur place; EUR 96 000 - 165 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson Innovative Medicine, a Johnson & Johnson family company, is recruiting for a Senior Manager, Quality Asset Management within Advanced Therapies. The role represents Global Quality on CMC and Value Chain teams, ensuring QA deliverables, and guiding product quality across lifecycle.

You will lead QA resources, coordinate with external partners, and support regulatory filings and inspections across global sites.

Qualifications

• Bachelor's degree in Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or similar technical field.
• 8+ years in pharmaceutical/biotech industry.
• Knowledge of cGMP standards, policies and procedures.
• Ability to work across organizational boundaries and influence stakeholders.

Responsabilités

• Represent Global Quality on CMC and Value Chain teams; liaison between VCT and Analytical group.
• Ensure Quality stage gate deliverables are achieved.
• Review/approve health authority submissions and respond to HA questions.
• Define and oversee QA resources for global/local QA of assigned products.
• Lead Quality new product integration team from development through launch.
• Coordinate with PQO Value Optimize & Late Stage on transfer of ownership.

Connaissances

GMP knowledge

Regulatory filings knowledge

Cross-functional collaboration

Risk assessment

Formation

Bachelor's degree in a scientific field

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

Job Function: Quality

Job Sub Function: Quality Assurance

Job Category: Professional

All Job Posting Locations: Brussels, Brussels-Capital Region, Belgium, Little Island, Cork, Ireland

Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Quality Asset Management within Advanced Therapies.

Key Responsibilities

• Represents Global Quality on the Chemistry, Manufacturing, and Controls (CMC) and Value Chain (VCT) Teams. Serves as liaison between VCT and Analytical group. Serves as the single point of Global Quality contact.
• Ensures Quality stage gate deliverables are achieved.
• Quality reviewer/approver of health authority submissions (i.e., IND, IMPD, BLA, NDA, MAA) and associated HA questions on the filings. Approves filings and questions for secondary filings. Support PAI and agency audits for the product(s) assigned.
• Defines and oversees the necessary QA resource for global and local QA of his or her assigned products.
• Leads a comprehensive Quality new product integration team that assures Quality throughout clinical, DS, DP, FF & device: development through launch.
• Leads a comprehensive Quality Sub team that assures Quality throughout clinical, DS, DP, FF & device:
• Ensures product quality development through product lifecycle.
• Supports the sites, represents the sites on CMC and VC teams.
• Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
• Ensures patients get the right quality products
• Ensures standard Global Quality processes (new product introduction processes and norms) are used across sites and facilitates communication throughout Global Quality.
• Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
• Supports preparation of the criticality analysis per schedule.
• Ensures complaints are well managed, issues are understood, and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics. Coordinates and/or owner of complaints trend signal investigations.
• Partners with Product Quality Owner (PQO) Value Optimize & Late Stage to complete Transfer of Ownership activities.
• Represents Global Quality on the Value Chain Teams (VCT):
• Maintains the flow of communications between Global Quality and VCT teams.
• Brings Quality issues to the VCT and assists with prioritization of projects and with key product decisions.
• Supports the business continuity process including VCT strategy and BCP projects.
• Reviews Proactive Product Quality Scans with the VCT and assures appropriate mitigating actions are defined there.
• Prepare quality sections of Product Strategy and End-to-end Value Chain Mapping.
• Participate in the F2F VCT meetings on PSR and VCM finalization and project prioritization.
• Align and interface the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.
• Presents project updates to QM for Global Quality alignment:
• Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions.
• Participates and actively engages on IMTs. Supports field/recalls as needed.
• Drives Decision making and Problem Solving:
• Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
• Gives input to the development of new strategies and implements and deploys strategies. Aids in the creation of product portfolio guidelines on the control strategy for new products which will influence the development strategy and the total quality cost during commercial production. These include decisions for Design for manufacturability, quality by design versus the cost of development, time to market.
• Aware that quality decisions made at any time during the development of new products can be revisited years later during regulatory inspections and reviews.
• Provides Quality structure, direction and decision making to the teams (Quality, CMC and VC Team) in situations of medium risk, uncertainty and ambiguity.
• Expected to bring creative solutions to define a compliant quality strategy with flexibility for business needs and more complex L&A deals, thus providing the best total value to the company.

Qualifications

Required

• A minimum of a bachelor’s degree with a major or concentration in one of the following: Pharmacy, Biology, Biochemistry, Biotechnology, Engineering, or a similar technical/scientific degree concentration
• A minimum of 8 years’ experience in the pharmaceutical, or biotechnology industry
• Knowledge of cGMP standards, policies and procedures
• Demonstrated ability to work across organizational boundaries through presenting, influencing, negotiation and partnering
• Ability to quickly assimilate new technologies, perform risk assessments and develop action plans
• Flexible hours to accommodate US, EMEA and ASPAC work schedules when necessary, balancing work and personal time is required
• This position may require up to 10% of domestic and international travel as business demands

Preferred

• A Master’s degree or other advanced degree
• Knowledge of biotech, vaccine, and/or sterile pharmaceutical manufacturing
• Experience in technology transfer, process development and/or process validation
• In-depth understanding of quality processes/systems (e.g. change control, event handling, CAPA), risk management and manufacturing control strategies
• Experience with developing and responding to quality content of regulatory filings, inspections, and preparedness activities
• Experience in API and Drug Product stability

Preferred Skills

Business Alignment, Collaboration, Compliance Management, Fact-Based Decision Making, Good Manufacturing Practices (GMP), ISO 9001, Mentorship, Organizing, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Environment, Standard Operating Procedure (SOP), Tactical Thinking, Technical Credibility

Salary

The anticipated pay range for this position, in the primary posting location, is: €96,000.00 - €165,025.00

The anticipated pay ranges for additional locations are:

• [Belgium] – The anticipated base pay range for this position is 96,000 EUR– 165,025 EUR.

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Equal Opportunity Statement

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.